Second, many of these same external edicts ultimately fell victim to medical reversal. The original EGDT protocol has evolved into an entirely different sepsis hydra. The pendulum is swinging back toward a conservative approach to patients with chest pain. The initial enthusiasm for high-dose steroids in spinal cord trauma has given way to concerns over harm and critically flawed methodology.
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ACEP Now: Vol 37 – No 06 – June 2018The same pervasive syndrome of medical reversal affects ED care, even when looking solely at trials published in such journals as The New England Journal of Medicine, Lancet, and JAMA.3 It should be clear by now there is great prudence in allowing additional evidence and evaluation to percolate through academic circles prior to adoption. The longer evidence is allowed to accumulate, the better understanding of patient-level factors influencing individual treatment response can be appreciated.
It’s Not a Slam Dunk
This circles back to tPA. We know tPA administration does not help every patient who receives it. A variety of factors influence whether the clot buster even lyses the clot. A variety of factors influence whether there is actually any surviving tissue behind the clot. Even proponents of tPA cite statistics in which the number needed to treat represents benefit for only the gross minority of patients.
That said, in the ED and in medicine in general, we provide many treatments in which only a small handful are expected to realize substantial benefit. We must treat 10 to 15 patients complaining of sore throat with dexamethasone for one to enjoy a clinically meaningful difference in symptomatic improvement. A similar number of antibiotic exposures would be needed to prevent a single case of recurrence after abscess drainage. The list is virtually endless, but many of these treatments remain commonplace because the costs and harms are considered relatively small.
This is not the case for tPA in acute ischemic stroke. A subset of patients will likely experience some benefit, but there is also known significant risk for intracranial hemorrhage, not to mention the profound financial costs associated with both the acute evaluation and subsequent hospitalization relating to tPA administration. However, the guidelines and certifications forced upon us offer little or no flexibility in narrowing the treatment population. Surprisingly, in 23 years little evidence or guidance has been offered to clarify the individual balance between risks and benefits.
This is where the opportunity for change exists and where ACEP leadership may play an important role. External guidelines affecting ED care must have representation from experts within our specialty to ensure their impact on our practice is not unreasonable. Additional efforts should be made to downgrade evidence produced solely by sponsored entities and to elevate the opinions of those without the voice and platform afforded to those with industry ties. Further, given the pervasiveness of medical reversal for novel treatments and pathways, it would be of great value for our leaders to firmly oppose a perceived standard of care until further independent confirmatory evidence may be accrued.
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3 Responses to “Is the tPA-for-Stroke Debate Over?”
June 24, 2018
Melvin JacksonBeen doing ED medicine for yes and totally embrace your article.Thanks
June 24, 2018
David Ghilarducci MDDr. Radecki laments what he perceives as hyperbole in the popular press then goes on to sarcastically call tPA the “blessed miracle drug”..a term never used in that article. Our patients deserve less tribalism in this debate.
June 24, 2018
Brian DoyleA must read for those interested in the stroke lysis debate. What a fantastic synopsis- in particular the focus on medical reversal.
But “sepsis hydra…?” That’s a new one.
Well done Ryan.